The global kidney function tests market size was USD 827.7 Million in 2021 and is expected to register a revenue CAGR of 6.3% during the forecast period. Growing incidence of kidney diseases such as Chronic Kidney Disease (CKD), rising research and development activities regarding various kidney function biomarkers as diagnostic tests as well as growing awareness about diagnostic methods in various hospitals, clinics, and other healthcare centers, are factors expected to drive market revenue growth during the forecast period.
Kidney function tests identify kidney or renal function disorders and assist doctors in prescribing for appropriate treatment. Renal function testing is essential in the therapy of patients suffering from kidney diseases. The global increase in the incidence and prevalence of kidney diseases such as chronic kidney disease, polycystic kidney disease, and acute kidney injury are key factors driving the global kidney function tests market. According to the Center for Disease Control and Prevention (CDC), as of 2021, more than 1 in 7, that is 15% of U.S. adults or 37 million people, are estimated to have CKD. Chronic kidney disease impacted 47 million people in the U.S. and are connected with high healthcare expenses, mortality, and morbidity. Since this condition can proceed slowly to advanced stages, early identification is crucial for implementing appropriate therapies, which have resulted in rising demand for kidney function diagnostics tests in the market, driving market revenue growth. For patients with risk factors, such as hypertension, diabetes, high blood pressure, and a history of cardiovascular disease, many guidelines advise at least annual screening with urine albumin/creatinine ratio, whole-blood creatinine, and urinalysis, which is also contributing to the market growth.
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The most common causes of kidney disease globally are hypertension, high blood pressure, heart disease, and diabetes. According to the National Kidney Foundation, hypertension and diabetes were the main indication in 76% of kidney failure cases: 47% of new kidney failure with replacement therapy (KFRT) patients had reported diabetes as their initial diagnosis and the main cause of kidney failure, and 29% of new KFRT patients reported hypertension as their initial diagnosis, which was the second leading cause of KFRT. Most doctors use kidney function tests to keep track of the progress whenever patients present symptoms related to these key causes. According to previous studies, rates of renal function tests were higher for all studied comorbidities. With the exception of diabetes, the frequency of testing appeared to have dropped over time across all other comorbidities and conditions. Patients with hypertension and diabetes had the greatest rate of serum creatinine tests. The application of kidney function tests assists in the early detection of these patients suffering from comorbidities and enables intervention in the early phases of disease progression. Certain kidney function diagnostics tests help in diagnosing these risks during the initial stages and hence estimate the timeframe to allow for peritoneal dialysis and advance schedules for transplant consideration in patients who will require renal replacement therapy or dialysis. Health plans can better coordinate resource allocation to facilitate or delay the treatments or surgeries by prioritizing patients requiring these therapies, way in advance. As a result, these tests can lead to a higher quality of life for each patient as well as a possible cost reduction in healthcare for the long term.
Driver: Rising developments in diagnostic testing methods for early diagnosis of renal disorders along with increasing clinical research regarding various kidney function biomarkers as diagnostic tests
Rising developments in diagnostic testing methods for early diagnosis of renal disorders or diseases affecting kidney function are driving revenue growth in the market. For example, when compared to current practice using laboratory blood tests, point-of-care (PoC) creatinine testing for the identification and monitoring of chronic kidney disease delivers enhanced accuracy and value in the monitoring and early identification of CKD. Rapid creatinine level results from such PoC testing provide immediate input and information to the patient. This type of testing provides real-time kidney function updates, which are essential for dose adjustments owing to renal impairment. They also offer rapid and accurate home testing, which allows for continuous monitoring, early diagnosis, and management of the deteriorated renal function. The Nova Statsensor, developed by Nova Biomedical in the U.S., takes only 1.2 microliters of blood for analysis; thus, fingerprick blood collection is adequate.
Clinically, the most useful tests for assessing renal function are those that measure the Glomerular Filtration Rate (GFR) and also detect proteinuria, such as Albumin to Creatinine Ratio (ACR) tests. However, GFR cannot be always quantified easily in most clinical or research contexts, hence early detection of Chronic Kidney Disease rely on filtration biomarkers such as cystatin C (CysC) and serum creatinine (SCr).
As a result, additional specific and sensitive biomarkers are presently being tested in clinical trials for early detection of CKD and improving patients’ prognoses, thus, addressing critical unmet medical needs. The investigation for new biomarkers is centered on better indications of renal dysfunction than GFR, as well as markers of specific forms of kidney injury measured in serum and urine. Specific biomarker research investigations would allow the diagnosis of kidney disease and reflect the underlying pathophysiological mechanisms of kidney damage. For instance, radioisotopes such as technetium-99-labeled diethylene-triamine-pentaacetate (99 Tc-DTPA) and chromium-51 ethylene-diamine-tetra-acetic acid (51 Cr-EDTA) are utilized as exogenous markers. Lohexol, a non-radioactive contrast agent, is the most effective exogenous marker, particularly in children. These factors are expected to drive revenue growth of the market during the forecast period.
Restraint: Low precision of prediction models based on kidney function tests and overuse of kidney function tests
The Cockcroft-Gault [C-G] and Modification of Diet in Renal Disease [MDRD] equations are two key prediction equations for adults based on serum creatinine readings from kidney function tests. These prediction equations based on kidney function tests are found to be inaccurate in case of patients with normal and near-normal kidney function, which may lead to misdiagnosis and inaccurate assessment of renal function in patients. According to recent guidelines, the cystatin C-based prediction equation should not be used in clinical practice. The MDRD equation surpasses the C-G equation in general, but it presents a significant level of bias, dependent on creatinine assay calibration and low precision.
Furthermore, overuse of tests delivers little value to patients and increases the cost strain on healthcare systems. A cross-sectional assessment of U.S. physicians’ patterns of care in CKD patients found that 85% requested extra additional testing, which had not been advised in the Kidney Disease Improving Global Outcomes (KDIGO) guidelines. Rather than urine or blood tests, these examinations also include magnetic resonance angiography of renal arteries or serum protein electrophoresis. This results in patients undergoing more tests than necessary, and others not receiving tests required by their clinical history, current health, or age. These factors are expected to hamper market revenue growth during the forecast period.
COVID-19 has a positive impact and opens up new avenues for the intravenous immunoglobulin market. COVID-19 impairs the renal function of patients. According to Diagnostic Systems, in 2020, 40% of hospitalized COVID-19 patients had symptoms of decreased kidney functions, such as hematuria and albuminuria. Some of the kidney function biomarkers detected in COVID-19 patients with renal function problems included serum creatinine (Scr), Blood Urea Nitrogen (BUN), urine protein (PRO), urine occult blood urine (BLD), 24-h urine creatinine (UCr), 24-h urine K (UK), 24-h urine Na (UNa), microalbumin (UMA), 1-microglobulin (A1M), urine immunoglobulin G (IGU), and urine transferrin (T Scr) and BUN levels were frequently elevated during COVID-19. The detection of urine micro-proteins and the use of several indicator assessments could be useful in detecting abnormal renal function in COVID-19 patients.
COVID-19 shedding was frequently seen in the urine of people suffering from mild to severe sickness. Urinary viral shedding of COVID-19 has been reported in children with a moderate form of the virus. COVID-19 shedding was seen in the urine from day 1 to day 52 after the virus is detected. Urinalysis, a form of kidney function test, is used in such circumstances to evaluate urine viral shedding as well as to diagnose kidney and urinary tract abnormalities. These types of tests also help assess bodywide disorders, which include diabetes or liver problems. As a result of the increased frequency of corona-positive patients worldwide, the market for kidney function tests is expected to grow throughout the pandemic.
Based on type, the global kidney function tests market has been segmented into dipsticks, disposable, and reagents. A dipstick is a type of plastic stick with different chemicals striped on it. This assists in the detection of a wide range of renal and urinary tract issues, including CKD, bladder infections, and kidney stones. In emergency departments, urine dipsticks are routinely used to screen for white blood cells and other signs of urinary tract infections; to detect red blood cells in patients with suspected renal stones, and to identify ketones in diabetic patients suspected of having diabetes ketoacidosis (DKA). In CKD, dipsticks are used to test for amount of albumin present in urine. The dipstick test is advantageous since it is affordable, rapid, and noninvasive. Due to these benefits, researchers have investigated the urine dipstick’s utility as a diagnostic instrument for renal insufficiency, with the goal of eliminating the requirement for serum creatinine tests. The urine dipstick has previously been investigated as an outpatient regular screening test for both renal and cardiovascular disease. For instance, Siemens Healthineers partnered with the Israeli start-up Healthy.io to enable patients to test their urine at home using a smartphone camera that can scan a dipstick and transmits the test results to their doctor. These advancements are contributing to the revenue growth of this segment.
Product Type Outlook:
Based on product type, the global kidney function tests market has been segmented into Urine tests and Blood tests. The urine tests segment is further sub-segmented into urine protein test, glomerular filtration rate test, and microalbumin test. The urine tests segment is expected to register a rapid revenue growth rate during the forecast period due to the increasing adoption of rapid urine tests in the market. The quickest approach to test urine is using a rapid urine test. Rapid urine tests are typically performed as part of normal checkups, such as those performed at a family doctor’s office, during antenatal visits, when admitted to the hospital, or before surgery. They are also utilized in patients with acute symptoms such as lower abdomen discomfort, stomach ache, or back pain; frequent painful urination, or blood in their urine. Many compounds are found in urine only in specified amounts, so higher or lower levels signal a deviation from the normal, and these substances can be evaluated using a quick urine test, which includes pH value (a measure of acidity in urine ), Sugar, Ketone (a metabolic product), Nitrite, Urobilinogen, and Bilirubin (a breakdown product of hemoglobin). Urine tests are rising in demand due to its wide range of applications, which include the identification of Urinary Tract Infections (UTIs), kidney stones, diabetes, and so on. Furthermore, the identification of drug misuse done using urine tests, as well as rising adoption of point-of-care diagnostics due to their cost-effectiveness, easy accessibility, and usage, are expected to drive segment growth. Creatinine clearance tests are expected to boost segment revenue growth due to their great sensitivity and precision. These products are becoming increasingly popular due to their inexpensive costs and extensive availability. These factors are expected to drive revenue growth in this segment.
Based on end-use, the kidney function tests market has been segmented into hospitals and clinics, academic research laboratories, and diagnostic laboratories. The hospitals and clinics segment is expected to register a significantly robust revenue growth over the forecast period owing to an increase in hospital visits as people become more aware of chronic kidney disease and how to manage it. Furthermore, revenue growth of the segment is expected to be boosted by the advancement of infrastructure throughout various hospitals that aid in the performance of effective diagnostic processes.
Based on regional analysis, the kidney function tests market in Asia Pacific is expected to register a rapid revenue growth rate during the forecast period owing to the rapidly growing healthcare industry and increased investments by major industry participants. According to the National Center for Biotechnology Information (NCBI), the total incidence of chronic kidney disease in India is steadily increasing. Thus, the presence of a huge target audience in developing countries like India and China is expected to propel market growth during the forecast period. Rapid advancement in healthcare infrastructure and rising investments in research and development will boost market growth. With rise in diagnostics of primary immunodeficiency and growing awareness, there is increasing demand for immunoglobulin therapies. These are key factors driving revenue growth of the market in this region.
The kidney function tests market in North America is expected to account for largest revenue share during the forecast period owing to rising incidence of kidney diseases such as chronic kidney diseases among the population. According to the Centers for Disease Control and Prevention (CDC), 9 out of 10 individuals have untreated CKD, whereas 38% of the population aged 65 and up has been confirmed with CKD. Furthermore, according to the 2020 annual data report of the U.S. Renal Data System, around 786,000 residents in the U.S. were living with End-stage Kidney Disease (ESKD). The presence of major companies in the field and the availability of technologically advanced items are two key factors contributing to revenue growth of the market.
Market in North America is expected to account for largest revenue share during the forecast period owing to advantageous reimbursement policies and government regulations and guidelines, as well as an established healthcare infrastructure. The U.K. had the only nationalized and publicly funded healthcare system that introduced financial incentives to improve the quality of care for CKD patients. National government guidelines also propose quality requirements for CKD care, such as renal function monitoring, diagnosis, and treatment of cardiovascular risk factors.
Competitive landscape of the Kidney Function Tests Market is fragmented with many key players operating at global and regional levels. Key players are engaged in product development and strategic alliances to expand their respective product portfolios and gain a robust footing in the global market. Major players in the market include Abbott Laboratories, Danaher Corporation, Siemens Healthcare GmbH, Sysmex Corporation, Randox Laboratories Ltd., Baxter International Inc., F. Hoffmann-La Roche Ltd., Arkray, Inc., Acon Laboratories Inc., and Quest Diagnostic. Market players are undertaking various strategies, which are expected to drive market revenue growth during the forecast period.
- On 20 December 2021, Quest Diagnostic Incorporated acquired Labtech Diagnostics, an independent clinical diagnostic laboratory serving physicians and patients primarily in South and North Carolina, Georgia, and Florida entirety. Quest provides more communities in the Southeast with access to diagnostic innovation and insights, enabling them to live healthier lives. The Labtech laboratory in Anderson has joined the Quest Diagnostics global network, making it the first full-service Quest laboratory in South Carolina. More physicians in the state will be able to use Quest’s diagnostic services directly through its Cleveland HeartLab cardiometabolic center of excellence and additional laboratories in Atlanta, Tampa, and Greensboro, and North Carolina, as a result of the acquisition.
- On 16 September 2020, Baxter International Inc. announced an agreement for the NEPHROCLEARTM CCL14 diagnostic test with bioMérieux, a global leader in in-vitro diagnostics. Following regulatory clearance and launch in Europe and the US, Baxter will be bioMérieux’s sole distributor of the NEPHROCLEARTM CCL14 test in both places. BioMérieux will retain management of the regulatory approval process, while Baxter will share in-country commercialization. Baxter’s Acute Therapies portfolio is expanding with new diagnostic tools, advancing the company’s efforts to enhance overall patient management by offering solutions that allow essential care efficiency.
- On 22 September 2020, Renalytix AI, Inc., an artificial intelligence-enabled in-vitro diagnostics company, that optimizes clinical management of kidney disease, received a California Clinical Laboratory License for its clinical laboratory in Utah, the U.S. from the California Department of Health. KidneyIntelX now can be used to report risk assessment of progressive decline in kidney function for patients with early-stage Diabetic Kidney Disease (DKD). With this certification, the company has been licensed to provide KidneyIntelX testing services for its patients in 49 states.
Segments Covered in the Report
This report offers historical data and forecasts revenue growth at global, regional, and country levels and provides analysis of market trends in each of the sub-segment from 2022 to 2030. For this study, Reports and Data have segmented the Intravenous Immunoglobulin (Kidney function tests) Market based on type, product, end-use, and region:
Segments covered By Type Outlook, Product Outlook, End-use Outlook, Regional Outlook
By Type Outlook
By Product Outlook
By End-use Outlook
Hospitals and Clinics
Academic Research Laboratories
Middle East & Africa
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